Sunday, June 7, 2009

FDA Reverses Earlier Decision, Approves Schizophrenia Drug

The new antipsychotic medication has pharmacological and clinical profiles similar to those of other second-generation drugs on the market and appears to carry comparable risks.

After being turned down by the Food and Drug Administration (FDA) almost a year ago, iloperidone has gained approval for the acute treatment of schizophrenia in adult patients.

Iloperidone is a second-generation antipsychotic (SGA) medication mixed antagonism for dopamine D2 and serotonin 5HT2A receptors and is owned by Vanda Pharmaceuticals.

In two randomized, placebo-controlled, phase-3 trials in patients with schizophrenia, iloperidone was found more efficacious than placebo in reducing schizophrenia symptoms among study subjects.

In one trial, 604 patients with schizophrenia received iloperidone 24 mg/day, placebo, or ziprasidone for four weeks, with patients on iloperidone showing significant benefits in Positive and Negative Syndrome Scale total scores compared with placebo. In the other trial, involving 706 patients, iloperidone was compared with placebo and risperidone. After six weeks, the drug was superior to placebo in the reduction of total score on the Brief Psychiatric Rating Scale. The company did not release any data on how iloperidone compared with either ziprasidone or risperidone on efficacy indicators.